# FDA 483 - Pillar5 Pharma Inc. - December 15, 2023

Source: https://www.globalkeysolutions.net/records/483/pillar5-pharma-inc/49d12328-3ebf-4ca3-ade2-5b08703919fb

> FDA 483 for Pillar5 Pharma Inc. on December 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pillar5 Pharma Inc.
- Inspection Date: 2023-12-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pillar5 Pharma Inc., a manufacturer of sterile OTC drug products, received a Form 483 citing significant deficiencies. Observations included inadequate validation of aseptic processes, failures in investigating microbial excursions and consumer complaints, and deficiencies in their supplier qualification program for container/closure systems. These issues indicate a lack of robust quality control and process validation for sterile drug manufacturing.

## Related Documents

- [483 - 2020-02-21](https://www.globalkeysolutions.net/records/483/pillar5-pharma-inc/3fef87a0-f16d-4de4-bd43-7132bce6c38f)
- [483 - 2025-02-07](https://www.globalkeysolutions.net/records/483/pillar5-pharma-inc/aae128df-7323-4546-9ab7-cb02e0d26682)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/pillar5-pharma-inc/8b94b834-f2da-4821-9ddc-6795a5e6d6f0

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1